Biomarkers of Renal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBiorek S.R.L.
About this trial
The aim of the present study is the identification, in liquid biopsies, of a new molecular panel able to discriminate renal cancer patients from controls, to discriminate patients with a malignant lesion from those with a benign mass, to determine aggressiveness of RCC, and to differentiate the most common histological subtypes of RCC (clear cell, papillary 1, papillary 2, and chromophobe).
This new molecular panel will be combined with clinical parameters to provide a screening test and to improve the accuracy and specificity of diagnosis, prognosis, and histological classification of renal cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women over 18 years of age
Diagnosis of first episode of renal mass
Caucasian race
Signed, informed consent
Disqualifiers
Any other concomitant cancer or history of active cancer in the last 5 years
Oncological genetic syndrome
Previous history of renal tumour
Urothelial cancer
Trial population
Cases: patients diagnosed with a first episode of renal mass. Control subjects: living kidney donor or patient with urological functional diseases.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 2 trial groupsGroup A: Renal-mass patients
Group B: Control subjects
Trial outcomes
Primary outcomes
1
Screening
Identification of biomarkers able to predict the presence of a renal mass, defined as a mass either benign or malignant recorded at axial imaging examination (either CT or MRI).
Time frame
Analysis of biological samples collected before surgery2
Diagnosis
Identification of biomarkers able to predict the presence of a Renal Cell Carcinoma, defined as a renal malignancy
Time frame
Analysis of biological samples collected before surgery3
Prognosis
Identification of biomarkers able to predict the presence of an aggressive Renal Cell Carcinoma
Time frame
Analysis of biological samples collected before surgerySponsors and contacts
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Source ClinicalTrials.gov